Study of Default Options in Advance Directives

This study has been completed.

Sponsor:

Corporal Michael J. Crescenz VA Medical Center

ClinicalTrials.gov Identifier:

NCT01817686

First Posted: March 25, 2013

Last Update Posted: June 30, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood.

This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization.

The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.

The proportions of patients electing to receive each of the 5 specific life-extending interventions

Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU [ Time Frame: 18 months ]

The proportion of time during a 6-18 month follow-up (median 1 year) that patients spend in the hospital or ICU for each AD group

Other Outcome Measures:

To document feasibility of a study of Advance Directives in the Veteran population [ Time Frame: 18 months ]

To document our ability to recruit and retain patients with advanced diseases, we will measure the proportions of patients approached for consent who enroll (consent rate), the proportion of such patients who complete their AD (completion rate), and the proportion who subsequently complete their advance care satisfaction interview (retention rate).

ADs with pre-selected defaults that focus on providing comfort at end-of-life.

Other: Comfort Default AD forms

Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.

Experimental: Life Extension Default

ADs with pre-selected defaults that focus on extending life.

Other: Life Extension Default AD forms

Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.

Experimental: Standard Default

ADs without pre-selected defaults.

Other: Standard Default AD forms

Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.

Eligibility

Information from the National Library of Medicine

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